{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "216375", "product_res_number": "Z-0432-2026", "event_date_initiated": "2025-09-23", "event_date_posted": "2025-11-05", "recall_status": "Open, Classified", "res_event_number": "97708", "product_code": "KWY", "k_numbers": [ "K143113" ], "product_description": "Brand Name: Klassic BiPolar Head\n\nModel/Catalog Number: \n3205.41.022\tKlassic BiPolar Head, 41 mm OD, 22 mm Head;\n3205.42.022\tKlassic BiPolar Head, 42 mm OD, 22 mm Head;\n3205.43.022\tKlassic BiPolar Head, 43 mm OD, 22 mm Head;\n3205.44.028\tKlassic BiPolar Head, 44 mm OD, 28 mm Head;\n3205.45.028\tKlassic BiPolar Head, 45 mm OD, 28 mm Head;\n3205.46.028\tKlassic BiPolar Head, 46 mm OD, 28 mm Head;\n3205.47.028\tKlassic BiPolar Head, 47 mm OD, 28 mm Head;\n3205.48.028\tKlassic BiPolar Head, 48 mm OD, 28 mm Head;\n3205.49.028\tKlassic BiPolar Head, 49 mm OD, 28 mm Head;\n3205.50.028\tKlassic BiPolar Head, 50 mm OD, 28 mm Head;\n3205.51.028\tKlassic BiPolar Head, 51 mm OD, 28 mm Head;\n3205.52.028\tKlassic BiPolar Head, 52 mm OD, 28 mm Head;\n3205.53.028\tKlassic BiPolar Head, 53 mm OD, 28 mm Head;\n3205.54.028\tKlassic BiPolar Head, 54 mm OD, 28 mm Head;\n3205.55.028\tKlassic BiPolar Head, 55 mm OD, 28 mm Head;\n3205.56.028\tKlassic BiPolar Head, 56 mm OD, 28 mm Head;\n3205.58.028\tKlassic BiPolar Head, 58 mm OD, 28 mm Head;\n3205.60.028\tKlassic BiPolar Head, 60 mm OD, 28 mm Head", "code_info": "Part Number/UDI/Lot Number:\n3205.41.022\t00814703011931\n3205.42.022\t00814703011948\n3205.43.022\t00814703011955\n3205.44.028\t00814703011962\n3205.45.028\t00814703011979\n3205.46.028\t00814703011986\n3205.47.028\t00814703011993\n3205.48.028\t00814703012006\n3205.49.028\t00814703012013\n3205.50.028\t00814703012020\n3205.51.028\t00814703012037\n3205.52.028\t00814703012044\n3205.53.028\t00814703012051\n3205.54.028\t00814703012068\n3205.55.028\t00814703012075\n3205.56.028\t00814703012082\n3205.58.028\t00814703012105\n3205.60.028\t00814703012129", "firm_fei_number": "3008544874", "recalling_firm": "Total Joint Orthopedics, Inc.", "address_1": "1567 E Stratford Ave", "city": "Salt Lake City", "state": "UT", "postal_code": "84106-3559", "additional_info_contact": "Brendan Perkins\n801-4866070", "reason_for_recall": "Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.", "root_cause_description": "Packaging", "action": "On September 5, 2025 Total Joint issued customer a Field action notification. On September 23, 2025, Total Joint issued a Urgent Medical Device Recall Notification. Total Joint ask consignees to take the following actions:\n\n1. Stop implanting the affected product.\n\n2. Locate and quarantine all affected inventory.\n\n3. With preliminary info we initially sent a Market Withdrawal notification on 9/05/2025 to initiate the quarantining and return of all BiPolar Heads in your possession. \n\n4. A list of all BiPolar Heads in your possession as of 9/05/2025 is shown within the letter, if you have already returned them we appreciate your swift response, if not please return these items immediately.\n\n5. Please complete and return the attached acknowledgment form confirming receipt of this notice and detailing the quantities returned. If inventory discrepancies are identified, please note that in the Return Response Box.\n\n6. Please contact Total Joint Orthopedics at (801)486-6070 with any questions or concerns.", "product_quantity": "103 units", "distribution_pattern": "US Nationwide distribution in the states of Ohio, Texas, Florida, Georgia, and North Carolina.", "openfda": { "k_number": [ "K152439", "K982812", "K101670", "K905370", "K925420", "K853795", "K132539", "K944132", "K982389", "K953977", "K925536", "K123991", "K823482", "K052990", "K941534", "K842344", "K253357", "K961793", "K100151", "K991990", "K180130", "K873514", "K945518", "K900051", "K833991", "K040947", "K223441", "K980801", "K953510", "K191016", "K023743", "K945793", "K080979", "K926387", "K112019", "K884658", "K970447", "K781735", "K220492", "K062693", "K982447", "K925153", "K010081", "K810062", "K855231", "K872019", "K163081", "K881289", "K823726", "K082468", "K200709", "K791823", "K050966", "K981238", "K833175", "K861105", "K100761", "K191297", "K861566", "K833404", "K080647", "K963885", "K812672", "K013211", "K970284", "K183114", 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